Clinical trial · Observational
Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
NCT04022109CI-TRIAL-00052889VOGASrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is aimed to determine the potential of volatile marker testing for gastric cancer screening. The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrophic Gastritis | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Dysplasia | — | UNRESOLVED | — |
| H.Pylori Infection | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breath sampling for VOC detection | Device | — | UNRESOLVED |
| Microbiota testing | Diagnostic Test | — | UNRESOLVED |
| Surgery material collection for VOC headspace analysis | Procedure | — | UNRESOLVED |
| Upper endoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Gastric cancer patients undergoing surgery
- description
- Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management
- interventionNames
- Device: Breath sampling for VOC detection
- Procedure: Surgery material collection for VOC headspace analysis
- Diagnostic Test: Upper endoscopy
- Diagnostic Test: Microbiota testing
- label
- Gastric cancer patients
- description
- Patients with histologically confirmed gastric cancer (adenocarcinoma)
- interventionNames
- Device: Breath sampling for VOC detection
- Diagnostic Test: Upper endoscopy
- Diagnostic Test: Microbiota testing
- label
- Control group patients without gastric cancer
- description
- Patients without gastric malignant disease according to data obtained in upper endoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with verified gastric cancer (Group 1 \& 2) * Patients undergoing or having undergone upper endoscopy according to clinical indications (Group 3 \& 5) * Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 4) * Motivation to participate in the study * Physical status allowing volatile marker sampling and other procedures within the protocol * Signed consent Exclusion Criteria: * Known other active cancer * Ventilation problems, airway obstruction * Unwillingness or inability to co-operate
References
Publications (6)
- BACKGROUNDMochalski P, Leja M, Gasenko E, Skapars R, Santare D, Sivins A, Aronsson DE, Ager C, Jaeschke C, Shani G, Mitrovics J, Mayhew CA, Haick H. Ex vivo emission of volatile organic compounds from gastric cancer and non-cancerous tissue. J Breath Res. 2018 Jul 30;12(4):046005. doi: 10.1088/1752-7163/aacbfb. PMID 29893713
- BACKGROUNDKrilaviciute A, Stock C, Leja M, Brenner H. Potential of non-invasive breath tests for preselecting individuals for invasive gastric cancer screening endoscopy. J Breath Res. 2018 Apr 4;12(3):036009. doi: 10.1088/1752-7163/aab5be. PMID 29528036
- BACKGROUNDAmal H, Leja M, Funka K, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Haick H. Detection of precancerous gastric lesions and gastric cancer through exhaled breath. Gut. 2016 Mar;65(3):400-7. doi: 10.1136/gutjnl-2014-308536. Epub 2015 Apr 13. PMID 25869737
- BACKGROUNDKrilaviciute A, Heiss JA, Leja M, Kupcinskas J, Haick H, Brenner H. Detection of cancer through exhaled breath: a systematic review. Oncotarget. 2015 Nov 17;6(36):38643-57. doi: 10.18632/oncotarget.5938. PMID 26440312
- BACKGROUNDLeja M, You W, Camargo MC, Saito H. Implementation of gastric cancer screening - the global experience. Best Pract Res Clin Gastroenterol. 2014 Dec;28(6):1093-106. doi: 10.1016/j.bpg.2014.09.005. Epub 2014 Sep 28. PMID 25439074
- BACKGROUNDLeja M, Amal H, Lasina I, Skapars R, Sivins A, Ancans G, Tolmanis I, Vanags A, Kupcinskas J, Ramonaite R, Khatib S, Bdarneh S, Natour R, Ashkar A, Haick H. Analysis of the effects of microbiome-related confounding factors on the reproducibility of the volatolomic test. J Breath Res. 2016 Jun 24;10(3):037101. doi: 10.1088/1752-7155/10/3/037101. PMID 27341527